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Content - PROSPECT

PROSPECT - Treatment of rectal cancer with combined radiotherapy and chemotherapy or chemotherapy alone, followed in each case by surgical removal of the tumour

The PROSPECT study is concerned with the treatment of rectal cancer. Patients with only a few affected lymph nodes and a tumour that has not yet infiltrated other organs (stages T2 and T3) and can be removed with a safety margin are eligible to enroll.

Such tumours are usually treated by combined radiotherapy and chemotherapy followed by surgical removal of the tumour and subsequent chemotherapy.

The PROSPECT study is investigating whether radiotherapy can be omitted in some patients without impairing their chances of a cure. If this treatment strategy should prove correct, omitting radiotherapy could simplify treatment and may mean fewer side effects.

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Inclusion criteria

Radiologically measurable or clinically evaluable disease as defined in the protocol

ECOG Performance Status (PS): 0, 1 or 2

For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined modality neoadjuvant chemoradiation followed by curative intent surgical resection

Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon

Primary surgeon is credentialed or is willing to be credentialed in Total Mesorectal Excision (TME), which entails submission of photos of a single TME specimen either before enrolling the first patient or by using the surgeon's 1st accrued case.

Clinical Stage: T2N1, T3N0, T3N1.

N2 disease is to be estimated as four or more lymph nodes that are ≥ 10 mm.

Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon, CT or PET/CT scan of the chest/abdomen/pelvis and either a pelvic MRI or an ultrasound (ERUS). If a pelvic MRI is peformed, it is acceptable to perform CT of the chest/abdomen, ommitting CT imaging of the pelvis.

The following laboratory values obtained ≤ 28 days prior to registration:

Absolute neutrophil count (ANC) ≥ 1500/mm^3

Platelet count ≥ 100,000/mm^3

Hemoglobin > 8.0 g/dL

Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

SGOT (AST) ≤ 3 x ULN

SGPT (ALT) ≤ 3 x ULN

Creatinine ≤1.5 x ULN

Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only

Patient of child-bearing potential is willing to employ adequate contraception

Provide informed written consent

Willing to return to enrolling medical site for all study assessments

Exclusion criteria

Clinical T4 tumors

Primary surgeon indicates need for abdominoperineal (APR) at baseline

Evidence that the tumor is adherent to or invading the mesorectal fascia on imaging studies such that the surgeon would not be able to perform an R0 resection (one with negative margins)

Tumor is causing symptomatic bowel obstruction (patients who have had a temporary diverting ostomy are eligible).

Chemotherapy within 5 years prior to registration. Hormonal therapy is allowable if the disease free interval is ≥ 5 years.

Any prior pelvic radiation

Other invasive malignancy ≤ 5 years prior to registration. Exceptions are colonic polyps, non-melanoma skin cancer or carcinoma in-situ of the cer

Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects.

Pregnant women

Nursing women

Men or women of childbearing potential who are unwilling to employ adequate contraception

Co-morbid illnesses or other concurrent disease which, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.